ATX-01 / ARTHEx Biotech - LARVOL DELTA

ARTHEx Biotech Granted FDA Fast Track Designation for ATX-01 for the Treatment of Myotonic Dystrophy Type 1 (DM1) (PRNewswire) - "ARTHEx is currently advancing ATX-01 in the Phase I/IIa ArthemiR study and continues to work closely with regulatory authorities, clinical investigators, and patient advocacy groups to accelerate progress."

Fast track • Myotonic Dystrophy

ArthemiR: Study of ATX-01 in Participants With DM1 (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: ARTHEx Biotech S.L. | Trial completion date: Jun 2026 ➔ Jul 2027 | Trial primary completion date: Jun 2026 ➔ Jul 2027

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

ArthemiR: Study of ATX-01 in Participants with DM1 (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: ARTHEx Biotech S.L. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

ArthemiR: Study of ATX-01 in Participants With DM1 (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: ARTHEx Biotech S.L. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

ArthemiR: Study of ATX-01 in Participants With DM1 (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: ARTHEx Biotech S.L.

New P1/2 trial • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy